Pramipexole 0.5mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for dopamine D2 and D3 receptors. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum, thereby mimicking the effects of dopamine and compensating for dopamine deficiency in Parkinson's disease. For RLS, its mechanism is thought to involve dopaminergic activity in the substantia nigra and spinal cord.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty urinating
New or worsening mental, mood, or behavior changes

Some people have experienced sudden, uncontrollable sleepiness, including falling asleep while driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience excessive sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.

Additionally, some individuals have reported changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways while sitting, standing, or walking. These changes may occur several months after starting the medication or after a dose increase. If you notice any changes in your posture, contact your doctor.

Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms or if they bother you or persist, contact your doctor or seek medical attention:

Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
* If you are currently taking another medication that contains the same active ingredient as this drug.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. If you experience dizziness or lightheadedness, rise slowly from a sitting or lying position to minimize the risk of fainting. Be cautious when navigating stairs.

Follow your doctor's instructions for monitoring your blood pressure. Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the tapering schedule recommended by your doctor. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.

While taking this medication, refrain from consuming alcohol. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
• CNS depressants (e.g., alcohol, sedatives, hypnotics, opioids): May potentiate the sedative effects of pramipexole.

• Cimetidine: May decrease renal clearance of pramipexole, leading to increased plasma levels.
• Amantadine: Concomitant use may increase the risk of hallucinations and confusion.
• Levodopa: May increase the risk of dyskinesia and hallucinations when used concurrently with pramipexole.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations (visual, auditory)
• Delusions, paranoia, confusion
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Dyskinesia (in Parkinson's disease, especially with concomitant levodopa)
• Nausea, constipation
• Peripheral edema

Pramipexole is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pramipexole is excreted in rat milk and is expected to be excreted in human milk. It may inhibit lactation due to its dopamine agonist activity. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established for Parkinson's disease or restless legs syndrome. Use is generally not recommended.

Elderly patients (≥65 years) have reduced renal clearance of pramipexole, leading to higher plasma concentrations. Dose adjustment based on renal function is crucial. Elderly patients may also be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence.

• Titrate dose slowly to minimize side effects, especially orthostatic hypotension and somnolence.
• Counsel patients on the risk of sudden sleep attacks and impulse control disorders, and advise them to report these immediately.
• Renal function must be assessed before initiating treatment and periodically thereafter, as dose adjustments are critical in renal impairment.
• Pramipexole can cause augmentation in RLS (worsening of symptoms earlier in the day or spreading to other body parts) at higher doses; consider dose reduction or alternative therapy if this occurs.
• Withdrawal symptoms (e.g., akinesia, insomnia, depression, sweating) can occur if discontinued abruptly; taper dose gradually over several days to weeks.

• Other dopamine agonists (e.g., ropinirole, rotigotine patch, bromocriptine)
• Levodopa/carbidopa (for Parkinson's disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone)
• Amantadine
• For RLS: gabapentin enacarbil, iron supplementation (if deficient), opioids (severe cases), benzodiazepines (for sleep disturbance).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.